Advanced Solid TumorPhase 1NCT04936178
A Study of NB003 in Patients With Advanced Malignancies
A Phase 1 study testing NB003 tablets in people with Advanced Solid Tumor, run by Ningbo Newbay Technology Development Co., Ltd at 32 sites in 6 countries.
Trial summary
This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- NB003 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 6 Aug 2021to 1 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females of any race ≥18 years age.
- Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or other advanced malignancies.
- For dose escalation phase:
- GIST patients must have progressed on or had an intolerability to imatinib and other SoCs or refused other SoCs.
- Patients with an advanced solid tumor other than GIST must have relapsed or had refractory disease without an available effective therapy and harbor KIT or PDGFRα gene alterations (central laboratory confirmation is not required for screening).
- For dose expansion phase:
Show all 12Show fewer
- Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥ fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and sunitinib, and who have not received additional systemic therapy for advanced GIST (third line therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and who have not received additional systemic therapy for advanced GIST (forth line therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and have not received additional systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant to avapritinib; in the countries/regions where avapritinib is not SoC, avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic melanoma patients with demonstrated evidence for KIT gene mutation and/or amplification, must have progressed on or been intolerant to SoCs; Cohort 6: Patients with other advanced malignancies other than GIST or melanoma which must be relapsed or refractory without an available effective therapy and harbor KIT or PDGFRα gene alterations.
- For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Adequate organ and marrow function.
- Tumor sample collection is required.
Who cannot join
- Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum wash-out period of 21 days prior to the initiation of study drug administration.
- Major surgery within 4 weeks of the first dose.
- Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
- Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
- Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
- Any known active central nervous system metastases and/or carcinomatous meningitis. Active infection including hepatitis B, hepatitis C, and HIV.
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, uncontrolled pericardial effusion, uncontrolled pleural effusion, or any other conditions, which in the judgment of Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
- Any evidence of severe or uncontrolled systemic diseases which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Trial locations and contacts
32 sites in 6 countries.
32 sites in 6 countries
China19 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University People's Hospital
Beijing, Beijing Municipality, 100144
Xiangya Hospital, Central South University
Changsha, Huanan, 410008
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Fujian Cancer Hospital
Fuzhou, Fujian, 350015
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, 510000
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guandong, 510080
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, 310003
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201315
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai Municipality, 201315
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 453000
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
The Second Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shaanxi, 710004
United States6 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
U T MD Anderson Cancer Center Investigational Pharmacy Services
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Standford University
Stanford, California, 32224
France2 sites
Centre Léon Bérard
Lyon, Rhone, 69373
Institut Gustave Roussy
Villejuif, Val de Marne, 94805
South Korea2 sites
Asan Medical Center
Seoul, Seoul, 05505
Samsung Medical Center
Seoul, Seoul, 05505
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Madrid, 28040
United Kingdom1 site
Royal Marsden Hospital-London
London, London, SW36JJ
About this study
Official title: A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies
This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Malignancies
Read the detailed description
This is a phase 1, open-label, multicenter study of NB003 which comprised of a dose escalation phase to determine the MTD or maximum administered dose (MAD), and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of NB003.
The dose escalation phase will enroll patients with advanced gastrointestinal stromal tumor (GIST) who have progressed on or had an intolerability to imatinib and other standard of cares (SoCs) or refused other SoCs, and patients with advanced malignancies other than GIST that harbors KIT or PDGFRα gene alterations who have relapsed or have refractory disease without an available effective therapy. The number of patients to be enrolled during the dose escalation part will vary depending on the underlining dose-toxicity curve and the number of dose levels tested prior to reaching MTD or MAD. After the MTD or MAD has been determined, based on emerging safety/PK data, one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s) to establish the RP2D for dose expansion phase. This step will be regarded as RP2D confirmation part of dose escalation phase.
In the dose expansion phase, additional patients will be enrolled to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα. Dose expansion phase is planned to investigate NB003 at the RP2D determined from dose escalation phase.
- Conditions
- Advanced Solid Tumor
- Being tested
- NB003 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB003 tabletsDrug
NB003 tablets will be administered at assigned doses for escalation phase and RP2D doses for expansion phase orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase and Dose Expansion Phase | Experimental | Dose escalation cohort:
NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
RP2D: one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s)
Dose expansion phase:
In the dose expansion phase, additional patients will be enrolled at RP2D to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα. Receives: Drug: NB003 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities
Dose Escalation Phase：Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
Measured: Approximately 24 months since the escalation first subject enrolled
Incidence of adverse events
Dose Escalation Phase and Dose Expansion Phase: An AE is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.
Measured: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Objective Response Rate (ORR)
Dose Expansion Phase: Objective Response Rate (ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR)
Measured: Approximately 26 months since the Expansion first subject enrolled
Duration of Response(DOR)
Dose Expansion Phase: DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR.
Measured: Approximately 26 months since the Expansion first subject enrolled.
Secondary outcomes (6)
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Dose Escalation Phase and Dose Expansion Phase: AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Measured: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Maximum observed plasma concentration (Cmax)
Dose Escalation Phase and Dose Expansion Phase: Maximum observed plasma concentration (Cmax)
Measured: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Time to Cmax (Tmax)
Dose Escalation Phase and Dose Expansion Phase: Time to Cmax (Tmax)
Measured: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Terminal elimination half life
Dose Escalation Phase and Dose Expansion Phase: Terminal elimination half life
Measured: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Objective Response Rate (ORR)
Dose Escalation Phase: Objective Response Rate (ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR)
Measured: Approximately 24 months since the escalation first subject enrolled
Duration of Response(DOR)
Dose Escalation Phase: DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR.
Measured: Approximately 24 months since the escalation first subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start6 Aug 2021
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Newbay Technology Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936178
- Sponsor's protocol ID
- NB003-01
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04936178
- Acronym / sponsor ID
- NB003-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Ningbo Newbay Technology Development Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB003 in Subjects with Advanced Malignancies
Detailed description
This is a phase 1, open-label, multicenter study of NB003 which comprised of a dose escalation phase to determine the MTD or maximum administered dose (MAD), and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of NB003.
The dose escalation phase will enroll patients with advanced gastrointestinal stromal tumor (GIST) who have progressed on or had an intolerability to imatinib and other standard of cares (SoCs) or refused other SoCs, and patients with advanced malignancies other than GIST that harbors KIT or PDGFRα gene alterations who have relapsed or have refractory disease without an available effective therapy. The number of patients to be enrolled during the dose escalation part will vary depending on the underlining dose-toxicity curve and the number of dose levels tested prior to reaching MTD or MAD. After the MTD or MAD has been determined, based on emerging safety/PK data, one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s) to establish the RP2D for dose expansion phase. This step will be regarded as RP2D confirmation part of dose escalation phase.
In the dose expansion phase, additional patients will be enrolled to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα. Dose expansion phase is planned to investigate NB003 at the RP2D determined from dose escalation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase and Dose Expansion Phase | Experimental | Drug: NB003 tabletsDose escalation cohort: NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met. RP2D: one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s) Dose expansion phase: In the dose expansion phase, additional patients will be enrolled at RP2D to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females of any race ≥18 years age.
- Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or other advanced malignancies.
- Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥ fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and sunitinib, and who have not received additional systemic therapy for advanced GIST (third line therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and who have not received additional systemic therapy for advanced GIST (forth line therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and have not received additional systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant to avapritinib; in the countries/regions where avapritinib is not SoC, avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic melanoma patients with demonstrated evidence for KIT gene mutation and/or amplification, must have progressed on or been intolerant to SoCs; Cohort 6: Patients with other advanced malignancies other than GIST or melanoma which must be relapsed or refractory without an available effective therapy and harbor KIT or PDGFRα gene alterations.
- For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (8 listed)
- Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum wash-out period of 21 days prior to the initiation of study drug administration.
- Major surgery within 4 weeks of the first dose.
- Radiotherapy with a limited field of radiation for palliation within 1 week prior to the first dose, with the exception as defined.
- Patients currently receiving medications or herbal supplements known to be strong inhibitors or inducers of CYP3A4.
- Patients currently receiving acid-reducing agents and are unable to stop use at least 2 weeks prior to the first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB003 tabletsNB003 tablets will be administered at assigned doses for escalation phase and RP2D doses for expansion phase orally twice daily for repeated 28-day cycles until discontinuation criteria are met. | Drug | Dose Escalation Phase and Dose Expansion Phase |
Primary outcome
Incidence of dose-limiting toxicities
Time frame: Approximately 24 months since the escalation first subject enrolled
Dose Escalation Phase：Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
Incidence of adverse events
Time frame: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Dose Escalation Phase and Dose Expansion Phase: An AE is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.
Objective Response Rate (ORR)
Time frame: Approximately 26 months since the Expansion first subject enrolled
Dose Expansion Phase: Objective Response Rate (ORR) which is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR)
Duration of Response(DOR)
Time frame: Approximately 26 months since the Expansion first subject enrolled.
Dose Expansion Phase: DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR.
6 secondary outcomes
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Time frame: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Maximum observed plasma concentration (Cmax)
Time frame: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Time to Cmax (Tmax)
Time frame: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Terminal elimination half life
Time frame: Approximately 24 months since the escalation first subject enrolled; Approximately 26 months since the Expansion first subject enrolled
Objective Response Rate (ORR)
Time frame: Approximately 24 months since the escalation first subject enrolled
Duration of Response(DOR)
Time frame: Approximately 24 months since the escalation first subject enrolled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB003 tablets in people with Advanced Solid Tumor, run by Ningbo Newbay Technology Development Co., Ltd at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China, United States, France, South Korea, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (time frame: Approximately 24 months since the escalation first subject enrolled). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.